TABLE OF CONTENTS

USER MANUAL

1. Introduction

Welcome to the SoftComply eQMS!

A Quality Management System (QMS) is a collection of procedures and processes which describe how your organization carries out the development, distribution and maintenance activities to comply with the applicable standards and regulations.

Having a compliant QMS is the basic requirement to enter the medical device market worldwide.

The SoftComply eQMS is a Quality Management System packaged as an add-on for Confluence Server. It is based on the requirements of ISO 13485:2016, IEC 62304:2006 (as amended in 2008 and 2015), ISO 14971:2012 and 21 CFR 820, making it applicable for both the EU and the US markets.

Benefits of using the SoftComply eQMS

1. Kick-starts your FDA and ISO-compliant Quality Management System development with ready-made and pre-filled SOPs and templates – all you need to do is add your company and product development details in them!

2. Your QMS is a designated Space in your company’s Confluence – home to all of your QMS related documents!

3. You can easily copy QMS templates from your QMS Space into other project spaces that your company manages and that need to comply with your Quality System requirements – quickly managing the QMS requirements in various projects you run!

4. The QMS Example Space provides a full exemplary QMS of a sample company – your guide to finalizing your own QMS documentation!

A short video clip of SoftComply eQMS:

2. Quick User Guide

Note that the evaluation version of the SoftComply eQMS for Confluence Cloud only displays screenshots of the partial content of the add-on and creating the eQMS space in the trial version is disabled. After installing the full version of the SoftComply eQMS for Confluence Cloud, creating the space works exactly the same as in the Server version of the add-on.

2. After the successful installation, open the “Create Space” drop-down menu from the top navigation bar and create a new QMS Space.

3. The creation of the new QMS Space consists of these two simple steps:

3.1. Fill in Space Name, Space Key and the name of the Space editors;

3.2. Define Header and Footer content of all pages in the eQMS.

4. Customize the eQMS according to your Company’s business model, product and practices.

3. Setting up your QMS

3.1. A space in your Confluence – Home of Your QMS!

3. Fill in the Space name and assign the appropriate QMS space editors.The assigned editors will inherit automatic Space Admin rights, although it is always possible to modify these permissions through the usual Confluence space settings.These permissions can always be modified at a later stage using the standard Confluence user management.

Figure 3 – QMS Space Setup

4. Now you can insert the header and footer data that will show up on each page of your QMS manual, policy, SOPs and templates, i.e. company name and other specific details.

NOTE: Modifying headers and footers after this initial stage requires modifying each page separately! The bulk set up option shown below is available only during the initial setup of a space.

Figure 4 – Customize Headers and Footers of all your QMS documents

Figure 5 – Example of a header on a page of Quality Manual

Figure 6 – Example of a footer on a page of Quality Manual

5. The setup is complete! You have now created your company’s QMS space that contains the Quality Manual, the Quality Policy, 16 SOPs and 47 Templates. The Home Page of your QMS space provides you with a checklist for implementing the QMS throughout your company.

The ‘eQMS’ button brings you to the Home page of your QMS. The macro looks for the space in the category “qms_spaces”. This label should not be modified. The ’QMS Example Space’ has the “qms_example” flag and the ‘QMS Space (Trial mode)’ the “qms_spaces_trial” flag.

Figure 7 – QMS Homepage

The User Guide is a detailed look into each of the tasks in the checklist on your QMS Home Page that are required for setting up your QMS.

3.2. Customize your QMS

General

Several aspects of the eQMS must be tailored around your company’s activities and business model. Your QMS should reflect what your company does and should assist you in executing these processes in a compliant manner. It should not be viewed as a burden disconnected from the actual activities or a paper exercise!

In your QMS space documents you will have two types of text – normal text that is derived directly from the requirements of international standards, and the text in highlighted information-boxes that requires your attention and completion.

You should fill in this information based on the guidance described inside each box.

Figure 8 – Info boxes

Adding your company logo

Adding your company’s logo to the pages in your QMS gives you the opportunity to personalize the appearance of the QMS documents.

Adding and modifying you company logo is easy.

Just open and Edit the “Company Logo” page and replace the default logo with the one of your choice.

Adjust the size, position and other settings to optimize the appearance of your logo in your QMS pages.

Figure 9 – Company Logo Page

Figure 10 – Include Company Logo Macro Setup

This macro displays the logo or picture from a source page.

Figure 11 – Include Company Logo Macro

Adding your company name

Before setting up you Company’s QMS (as shown in Figure 4), all the documents have the company name as “ACME ltd” by default. This is just a placeholder and is replaced with the actual name of your company after the Setup of your QMS space.

Review the SOPs and Templates to ensure that the name appears correctly throughout!

Figure 12 – Company Name Setup

Displaying attachments

Some guidance in the eQMS is provided within attachments. For example, the two templates called “FMEA Template” and “Hazards Analysis Template”. These contain links from where the two excel files must be downloaded from, as Confluence does not currently support attachments in Space Blueprints.

Follow the directions in each information box; first download the files and then attach them to the page, so that the content will be displayed correctly.

Figure 13 – Download external Excel files

The rendering macro error is displayed because the macro won’t find the file to display until it is attached to the page. Once attached, the page will display the tables correctly.

Figure 14 – Link the Excel file in the macro

Adding functions and responsibilities

In several QMS documents it is required by regulations to list responsibilities for specific activities. These responsibilities are particularly important for the SOPs of your QMS. The person, or role, assigned with a specific responsibility must ensure that his/her owned procedures are maintained and correctly implemented within the company. The assignment of responsibilities depends on the structure and business model of your company.

Tailoring your company’s Quality Policy

The Quality Policy is a brief statement of how your company will ensure that the Quality System is effective. The Quality Policy in the QMS Example Space is a good guidance on how to tailor this document.

Tailoring your company’s Quality Manual

The Quality Manual is an overview of the Quality System, highlighting how your company is going to comply with the applicable standards.

It also contains the structure of the QMS, the company’s organizational structure and the description of the Management.

The Quality Manual in the QMS Example Space provides a good guidance on how to tailor this document.

Tailoring the content of your company’s SOPs

Most SOPs require specific content to be filled in around your company’s practices and business model. The QMS Example Space provides good guidance on how to tailor these SOPs.

Should you require additional assistance or support in managing the content of the QMS, do not hesitate to contact us at info@softcomply.com.

4. Rolling Out your QMS

Once you have completed the customization of your QMS, it’s time to release it throughout your company.

To manage documents’ change control, fill in the Change History table for each SOP, Template, Quality Manual and Quality Policy.

Note: Only the Template Change History must be populated at this time. It is accessible in the footer of each page in the Expand box.

Figure 15 – Roll Out

Follow your Document Control SOP to release the QMS.

Use handwritten signatures or an electronic signature system.

Training your company on QMS

All employees must be trained on the basics of your company’s QMS which includes the Quality Policy and the Quality Manual.

In addition, each employee must be trained on the specific aspects of the Quality System that he or she is responsible for or is going to use.

Deploying Templates

Each project or product should have its own Confluence space to manage the project related documentation.

A typical project space layout may be like the following:

1. My Test Project (Space)

1.1. Design History File.

– Phase 1

– Phase 2

– Phase 3

– Phase 4

– Phase 5

– Phase 6

1.2. Others

Each Phase will have the applicable documents listed as children (e.g. Device Lifecycle SOP).

In addition, it will be necessary to create other support spaces to house specific types of documents.

Each QMS template can be used for a specific scope or project by clicking on the “Copy Page” button at the top of the template.

Insert the target space name and parent page, then click OK, and Confluence will bring you to the edit mode of the copied page in the target space.

With this button you can copy read-only pages from read-only spaces.

Figure 16 – Copy Page Button

Figure 17 – Deploying Templates

5. Your Guide to Customization

1. The Example QMS included in the SoftComply add-on is a filled in, complete QMS. The purpose of the Example QMS Space is to provide guidance on how SOPs and Templates can be tailored. In other words, it can guide you in the customization of your own QMS space by providing an actual case of a working QMS.

2. Proceed in the same manner as the QMS space, but select instead “Example QMS Space”

Figure 18 – QMS Example Space

This will generate a fully deployed QMS space with filled in content.

Note that data and details present in this QMS example are not taken from actual or proprietary documents.

NOTE! Should you need additional support to finalize your QMS, please contact us – we have a network of medical device regulatory consultants working with us.

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